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Differentiated Thyroid CancerPhase 2NCT02870569

Phase 2 Trial of Donafenib in 131I-Refractory Differentiated Thyroid Cancer

A Phase 2 study testing Donafenib 200mg and Donafenib 300mg in people with Differentiated Thyroid Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Donafenib for advanced 131I-refractory/resistant differentiated thyroid cancer(DTC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Differentiated Thyroid Cancer
What is being tested?
Donafenib 200mg and Donafenib 300mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
Sep 2016to Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced or metastases thyroid cancer;
  • Subjects must have histologically or cytologically confirmed diagnosis of one of the following differentiated thyroid cancer (DTC) subtypes: papillary thyroid cancer (PTC),follicular thyroid cancer (FTC) or Hurthle cell ;
  • Measurable disease meeting the following criteria and confirmed by central radiographic review:
  • At least 1 lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computerized tomography.
  • Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radio-frequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion;
  • Bone metastases lesion is non-measurable.
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  • Subjects must show evidence of disease progression within 14 months prior to signing informed consent, according to RECIST 1.1 assessed and confirmed by central radio-graphic review of CT scans.
  • Subjects must be 131I-refractory / resistant as defined by at least one of the following:
  • One or more measurable lesions that do not demonstrate iodine uptake on any radio-iodine scan
  • One or more measurable lesions that has progressed by RECIST 1.1 within 14 months of 131I therapy, despite demonstration of radio-iodine avidity at the time of that treatment by pre-treatment scanning.
  • Cumulative activity of 131I of >600 mCi or 22 gigabequerels (GBq), with the last dose administered at least 6 months prior to study entry
  • Subjects may have not received molecular targeted therapy;
  • Subjects with known brain metastases who have completed whole brain radiotherapy, stereotactic radiosurgery or complete surgical resection, will be eligible if they have remained clinically stable, asymptomatic and off of steroids for one month
  • Subjects must tolerate to thyroxin ,and TSH suppression (TSH less than 0.1 mU/mL);
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~2；
  • Life expectancy of at least 3 months;
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) greater than or equal to 1500/mm3;
  • Platelets greater than or equal to 100,000/mm3 ;
  • Hemoglobin greater than or equal to 9.0g/dL
  • Adequate blood coagulation function:
  • Prothrombin time(PT)≤17s;
  • Activated prothrombin time(APTT)≤47s;
  • International Normalized Ratio(INR)≤2.
  • Adequate liver function:
  • Bilirubin less than or equal to 1.5 x the upper limit of normal(ULN) ;
  • Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 2.5 x the upper limit of normal (ULN).
  • All females must have a negative serum or urine pregnancy test. Females of childbearing potential and male subjects who are partners of women of childbearing potential must use or their partners must use a highly effective method of contraception;
  • Voluntary provision of written informed consent and the willingness and ability to comply with all aspects of the protocol.

Who cannot join

  • Anaplastic or Medullary carcinoma of the thyroid;
  • Prior treatment to sorafenib or other molecular targeted drugs;
  • Subjects who have received any chemotherapy or extra radiotherapy within 30 days prior to the first dose of study drug and should have recovered from any toxicity related to previous anti-cancer treatment;
  • Major surgery within 30 days prior to the first dose of study drug;
  • Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment;
  • Active infection (any infection requiring treatment);
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  • Active malignancy (except for differentiated thyroid carcinoma, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months;
  • Known intolerance to any of the study drugs (or any of the excipients);
  • All chemotherapy or radiation-related toxicities must have resolved to less than Grade 2 severity, except alopecia and infertility;
  • Adequately controlled blood pressure with or without antihypertensive medications, defined as BP less than 140/90 mmHg using at least 2 kinds of medicine;
  • Adequate renal function defined as calculated creatinine clearance less than or equal to 60 mL/min per the Cockcroft and Gault formula.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-Label,Phase 2 Trial of Donafenib in 131I-Refractory Differentiated Thyroid Cancer

Donafenib for advanced 131I-refractory/resistant differentiated thyroid cancer(DTC).

Read the detailed description

This phase 2 study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients with 131I-refractory/resistant differentiated thyroid cancer.The study is a randomised,multicentre,open-label study.

Being tested
Donafenib 200mg, Donafenib 300mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Donafenib 200mgDrug

    Also called lower dose

    Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects.The arm is the lower dose one.

  • Donafenib 300mgDrug

    Also called higher dose

    Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects.The arm is the higher dose one.

Study groups in NCT02870569
Study groupRoleWhat they receive
Donafenib1ExperimentalThis is the lower dose group. Donafenib 200mg bid
Receives: Drug: Donafenib 200mg
Donafenib2Active comparatorThis is the higher dose group. Donafenib 300mg bid
Receives: Drug: Donafenib 300mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate(ORR)

    ORR is defined as the percentage of subjects with total number of Complete Response(CR)+total number of Partial Response(PR).

    Measured: From randomization of the first subject until the last subject complete 24 months treatment

Secondary outcomes (4)

  1. Overall Survival (OS)

    OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact

    Measured: From randomization of the first subject until the last subject complete 48 months treatment

  2. Progression-free Survival (PFS)

    PFS was defined as the time from date of randomization to disease progression radiological or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

    Measured: From randomization of the first subject until the last subject complete 24 months treatment

  3. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Patients with adverse events/all patients *100%

    Measured: From randomization of the first subject until the last subject complete 24 months treatment

  4. Disease Control Rate(DCR)

    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)

    Measured: From randomization of the first subject until the last subject complete 24 months treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion2 Jul 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02870569
Sponsor's protocol ID
RG01N-1271
Status last verified
Aug 2017
First submitted
12 Aug 2016
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Sun D, Zhang X, Jin X, Shi C, Sun Y, Zhang Y, Liang J, Lin Y. BRAFV600E mutation is associated with better prognoses in radioactive iodine refractory thyroid cancer patients treated with multi-kinase inhibitors: a retrospective analysis of registered clinical trials. Thyroid Res. 2025 Feb 10;18(1):5. doi: 10.1186/s13044-025-00223-0.

    PubMed 39924483

  • Lin YS, Yang H, Ding Y, Cheng YZ, Shi F, Tan J, Deng ZY, Chen ZD, Wang RF, Ji QH, Huang R, Li LF. Donafenib in Progressive Locally Advanced or Metastatic Radioactive Iodine-Refractory Differentiated Thyroid Cancer: Results of a Randomized, Multicenter Phase II Trial. Thyroid. 2021 Apr;31(4):607-615. doi: 10.1089/thy.2020.0235. Epub 2020 Oct 15.

    PubMed 32907500

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donafenib 200mg and Donafenib 300mg in people with Differentiated Thyroid Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: From randomization of the first subject until the last subject complete 24 months treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870569, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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